A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

Janssen Research & Development, LLC57 enrolled

Overview

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

JNJ-61393215

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female of non-childbearing potential * Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT interval corrected for heart rate according to Fridericia's formula \[QTcF\] less-than or equal to \[\<=\] 450 milliseconds (ms) for males and \<= 470 ms for females) performed at screening * Before enrollment, female participants must be of non-childbearing potential, defined as: a) Postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes; b) Permanently sterile - Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy * Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight \< than 50 kg at screening * Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening Exclusion Criteria: * Clinically significant abnormal values for hematology, biochemistry, or urinalysis at screening as deemed appropriate by the investigator * Participants has any liver function test (including alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], gamma-glutamyltransferase \[GGT\], alkaline phosphatase \[ALP\], and bilirubin) at screening more than (\>)1.5\* upper limit of normal (ULN) * Participants has estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 61 milliliter (mL) / minute /1.73 per square meter (m\^2) at screening * Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening as deemed appropriate by the investigator * Known allergies, hypersensitivity, or intolerance to JNJ-61393215 or its excipients (or lactose)